BOSTON SCIENTIFIC CORPORATION ENDOVIVE SECURI-T; TUBES, GASTROINTESTINAL (AND ACCESSORIES)
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Model Number M00509161 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/15/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported to boston scientific corporation that an endovive securi-t replacement bolster was used during a percutaneous endoscopic gastrostomy replacement procedure on (b)(6) 2022.During the procedure, when the internal bolster was extended and inserted in the stoma, the internal bolster detached.The procedure was completed with a new endovive securi-t replacement bolster.There were no patient complications reported as a result of this event.
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Event Description
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It was reported to boston scientific corporation that an endovive securi-t replacement bolster was used during a percutaneous endoscopic gastrostomy replacement procedure on (b)(6) 2022.During the procedure, when the internal bolster was extended and inserted in the stoma, the internal bolster detached.The procedure was completed with a new endovive securi-t replacement bolster.There were no patient complications reported as a result of this event.
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Manufacturer Narrative
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Block h6 (device codes): device code a0501captures the reportable event of internal bolster.Block h10: the returned endovive securi-t replacement bolster was analyzed.Upon visual assessment, it was observed that silicone tube of the bolster was detached.Therefore, the complaint is confirmed.Based on the condition of the returned device, engineers determined that an excess of force has been applied; perhaps the manipulation, or technique used, could have contributed to this event.Boston scientific has determined the most probable cause of this complaint is adverse event related to procedure.
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